Garamycin

Package leaflet: Information for the patient

Garamycin, 2 mg/cm², sponge
Gentamicinum
Read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor, pharmacist, or nurse if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If any of the adverse reactions worsen or if any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

1. What Garamycin is and what it is used for
2. Important information before using Garamycin
3. How to use Garamycin
4. Possible side effects
5. How to store Garamycin
6. Contents of the pack and other information

1. What Garamycin is and what it is used for

Garamycin sponge is a sterile implant containing gentamicin sulfate, a broad-spectrum aminoglycoside antibiotic. It is used to provide a high local concentration of gentamicin, thereby eliminating local infection or preventing its development.
The collagen contained in the medicine has a haemostatic effect.
The medicine is intended for adjunctive treatment of bacterial infections of bone and soft tissues. It may be used during procedures on infected tissues or tissues at risk of infection, to prevent local soft tissue and bone infections (e.g. at bone graft sites and during cementless joint replacement surgery).
The patient will simultaneously receive an appropriate systemic antibiotic.

2. Important information before using Garamycin

When not to use Garamycin:

• if the patient is allergic to gentamicin or other aminoglycoside antibiotics, or to any of the other components of this medicine (listed in section 6);
• in patients with a history of immunological diseases or connective tissue disorders.

Warnings and precautions
Before starting treatment with Garamycin, consult a doctor, pharmacist, or nurse.
Special caution is required when using Garamycin:

• if the patient has impaired kidney function,
• if the patient suffers from neuromuscular disorders (muscle weakness, parkinsonism, or botulism in children), as muscle weakness may worsen,
• if the patient is simultaneously receiving other aminoglycoside antibiotics; serum concentration monitoring of these antibiotics or kidney function assessment (based on serum creatinine levels) may sometimes be necessary,
• if the patient has confirmed or suspected infection; in such case, a systemic-acting antibiotic selected according to microbiological test results will be administered.

Other medicines and Garamycin
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Concomitant use of gentamicin with potent diuretics such as ethacrynic acid or furosemide should be avoided, as such combination may cause ototoxicity. Intravenous administration of diuretics may enhance the toxic effects of aminoglycosides.
Avoid simultaneous or alternating use, either systemic or local, of drugs that act or may act harmfully on the nervous system, such as: cisplatin, streptomycin, kanamycin, cephaloridine, viomycin, polymyxin B, polymyxin E.

Pregnancy, breastfeeding, and fertility
During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.
Garamycin should be used in pregnant women only if absolutely necessary.
Due to the possibility of excretion of the drug into breast milk and the risk of severe adverse reactions in the infant, a decision must be made whether to discontinue breastfeeding or to avoid using the drug.

Driving and operating machinery
Garamycin sponge has no effect on the ability to drive mechanical vehicles or operate mechanical equipment.

3. How to use Garamycin

Garamycin is administered exclusively by a physician during a surgical procedure.
Dosage and method of administration are described at the end of the leaflet, under the section "Information intended solely for healthcare professionals".

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everybody experiences them.
The active substance of the medicine (gentamicin) may impair kidney function. Undesirable effects of gentamicin on the kidneys are manifested by the presence of casts, red blood cells and protein in the urine, or by increased blood levels of creatinine and urea nitrogen, as well as oliguria. These changes are usually mild. Such effects have been observed more frequently in patients who previously had kidney function disorders.
During treatment with this medicine, local redness, itching and increased wound exudate due to collagen resorption may occur.
Allergic reactions caused by the Garamycin sponge may occur in sensitive individuals.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Garamycin

Keep this medicine out of the reach and sight of children.
Store at a temperature not exceeding 25°C.
Do not use Garamycin after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Do not use Garamycin if the blister containing the sponge is damaged.
Garamycin should be used immediately after opening the outer packaging; otherwise, it must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Garamycin contains

• The active substance is gentamicin in the form of gentamicin sulfate. A sponge of dimensions 5 × 20 × 0.5 cm or 10 × 10 × 0.5 cm contains 130 mg gentamicin as gentamicin sulfate (200 mg). A sponge of dimensions 5 × 5 × 0.5 cm contains 32.5 mg gentamicin as gentamicin sulfate (50 mg).
• The other ingredients are purified collagen from bovine tendons.

What Garamycin looks like and contents of the pack
Gelatin sponge in a blister made of polyethylene terephthalate with glycol additive (PTEG)/Tyvek 1073B, in a bag
PET/PE/Tyvek 1073B, placed in a cardboard box.
The pack contains: 1 sponge, 5 or 10 sponges of dimensions 5 × 20 × 0.5 cm, 10 × 10 × 0.5 cm or 5 × 5 ×
0.5 cm.

Marketing Authorisation Holder and Manufacturer
SERB SA
Avenue Louise, 480
1050 Brussels
Belgium
For further information, please contact the representative of the Marketing Authorisation Holder: tel. +48 (0)22 307 03 61

Information intended exclusively for medical professionals

Route of administration
Remove the blister from the outer packaging under aseptic conditions. Then, under sterile conditions, remove the implant from the blister. The implant must be used dry only. Wetting the Garamycin sponge before application may result in loss of efficacy due to premature washout of water-soluble gentamicin sulfate.

The implant should be used immediately after opening the outer packaging; otherwise, it must be discarded. The product must not be re-sterilized.

Placement into soft tissues (treatment and prophylaxis): usually one sponge is used (maximum of three sponges of size 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm). For smaller defects, the sponge may be cut into smaller pieces in the surgical field.

Osteomyelitis and other indications for use in bone tissue (treatment of infections and prophylaxis): usually one sponge is used (maximum of five sponges of size 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm).

The dose size (number of sponges) depends on the extent of the surgical area and the size of the lesion being treated. In patients with body weight not exceeding 50 kg, the recommended maximum simultaneous dose (number of sponges) is three; for patients above 50 kg, up to five sponges of size 10 × 10 × 0.5 cm or 5 × 20 × 0.5 cm.

General application method of the sponge: local (in situ) or topical application to the skin.

After surgical wound debridement, the sponge is inserted into the wound. The Garamycin sponge is soft and can be trimmed to the desired size using standard surgical scissors. Dry gloves and instruments should be used, as the sponge may become sticky in a wet environment. The product has been used in various ways (whole sponge, shaped into different forms, cut into pieces); it has been placed flat, rolled into a cylinder, folded loosely into the wound (soft tissues), or tightly pressed against the bone. It has also been placed around the wound, cut into small pieces, and mixed with morsellized cancellous bone, then implanted together into the bone defect.

In adjunctive treatment and prophylaxis of infections, the Garamycin sponge is applied in situ to fully cover (including a small margin) the surgical site or the portion requiring local antibiotic therapy.

In all bone surgeries, care must be taken to ensure stability of the bone union, as even minor instability may not present clinically but could lead to infection (especially by Staphylococcus aureus).

Concurrent use of active drainage (suction drainage) and application of the Garamycin sponge product is not recommended. Consider administering the product after termination of such drainage. It is possible to use the Garamycin sponge together with passive gravitational drainage. In such cases, the product should be applied so as not to cover the drainage lumen.

The product must not be removed from the site of placement.